Prostheses and Methods of Replacement of Natural Facet Joints with Artificial Facet Joint Surfaces

ABSTRACT

Cephalad and caudal vertebral facet joint prostheses and methods of use are provided. The cephalad prostheses are adapted and configured to be attached to a lamina portion of a vertebra without blocking a pedicle portion of the cephalad vertebra. In some embodiments, the prosthesis is attached with a non-invasive support member, such as a clamp. In other embodiments, a translaminar screw may be used for additional fixation.

CROSS REFERENCE

This application is a continuation application of Ser. No. 11/460,934,filed Jul. 28, 2006, for Prostheses and Methods for Replacement ofNatural Facet Joints with Artificial Facet Joint Surfaces by Stinson etal., which is a continuation of Ser. No. 11/275,447, filed Jan. 3, 2006,for Prosthesis, Tools and Methods for Replacement of Facet Joints withArtificial Facet Joint Surfaces by Stinson et al., which is acontinuation of Ser. No. 10/615,417, filed Jul. 8, 2003, for Prosthesis,Tools and Methods for Replacement of Facet Joints with Artificial FacetJoint Surfaces by Stinson et al., now U.S. Pat. No. 7,074,238, which areall incorporated herein by reference in their entirety and to whichapplication priority is claimed under 35 USC §120.

FIELD OF THE INVENTION

This invention relates to prostheses for treating various types ofspinal pathologies, as well as to methods of treating spinalpathologies.

BACKGROUND OF THE INVENTION I. Vertebral Anatomy

As FIG. 1 shows, the human spinal column 10 is comprised of a series ofthirty-three stacked vertebrae 12 divided into five regions. Thecervical region includes seven vertebrae 12, known as C1-C7. Thethoracic region includes twelve vertebrae 12, known at T1-T12. Thelumbar region contains five vertebrae 12, known as L1-L5. The sacralregion is comprised of five vertebrae 12, known as S1-S5. The coccygealregion contains four vertebrae 12, known as Co1-Co4.

FIG. 2 shows a normal human lumbar vertebra 12. Although the lumbarvertebrae 12 vary somewhat according to location, they share manyfeatures common to most vertebrae 12. Each vertebra 12 includes avertebral body 14 and posterior elements as follows:

Two short bones, the pedicles 16, extend backward from each side of thevertebral body 14 to form a vertebral arch 18. At the posterior end ofeach pedicle 16 the vertebral arch 18 flares out into broad plates ofbone known as the laminae 20. The laminae 20 fuse with each other toform a spinous process 22. The spinous process 22 serves for muscle andligamentous attachment. A smooth transition from the pedicles 16 intothe laminae 20 is interrupted by the formation of a series of processes.

Two transverse processes 24 thrust out laterally on each side from thejunction of the pedicle 16 with the lamina 20. The transverse processes24 serve as levers for the attachment of muscles to the vertebrae 12.Four articular processes, two superior 26 and two inferior 28, also risefrom the junctions of the pedicles 16 and the 15 laminae 20. Thesuperior articular processes 26 are sharp oval plates of bone risingupward on each side from the union of the pedicle 16 with the lamina 20.The inferior processes 28 are oval plates of bone that extend in aninferior direction on each side.

The superior and inferior articular processes 26 and 28 each have anatural bony structure known as a facet. The superior articular facet 30faces upward or superiorly, while the inferior articular facet 31 facesdownward. As FIG. 3 shows, when adjacent (i.e., cephalad 25 and caudal)vertebrae 12 are aligned, the facets 30 and 31, capped with a smootharticular cartilage, interlock to form a facet joint 32, also known as azygapophysial joint.

The facet joint 32 is composed of a superior half and an inferior half.The superior half is formed by the vertebral level below the joint 32,and the inferior half is formed by the vertebral level above the joint32. For example, in the L4-L5 facet joint, the superior portion of thejoint is formed by bony structure on the L-5 vertebra (e.g., a superiorarticular surface and supporting bone on the L-5 vertebra), and theinferior portion of the joint is formed by bony structure on the L-4vertebra (e.g., an inferior articular surface and supporting bone on theL-4 vertebra).

As also shown in FIG. 3, an intervertebral disc 34 between each pair ofvertebrae 12 permits relative movement between vertebrae 12. Thus, thestructure and alignment of the vertebrae 12 permit a range of movementof the vertebrae 12 relative to each other.

II. Facet Joint Dysfunction

Back pain, particularly in the “small of the back”, or lumbosacral(L4-S1) region, is a common ailment. In many cases, the pain severelylimits a person's functional ability and quality of life. Such pain canresult from a variety of spinal pathologies.

Through disease or injury, the laminae, spinous process, articularprocesses, or facets of one or more vertebrae can become damaged, suchthat the vertebrae no longer articulate or properly align with eachother. This can result in an undesired anatomy, pain or discomfort, andloss of mobility.

For example, the vertebral facet joints can be damaged by eithertraumatic injury or by various disease processes. These diseaseprocesses include osteoarthritis, ankylosing spondylolysis, anddegenerative spondylolisthesis. The damage to the facet joints oftenresults in pressure on nerves, also called a “pinched” nerve, or nervecompression or impingement. The result is pain, misaligned anatomy, anda corresponding loss of mobility. Pressure on nerves can also occurwithout facet joint pathology, e.g., a herniated disc.

One type of conventional treatment of facet joint pathology is spinalstabilization, also known as intervertebral stabilization.Intervertebral stabilization prevents relative motion between thevertebrae. By preventing movement, pain can be reduced. Stabilizationcan be accomplished by various methods.

One method of stabilization is posterior spinal fusion. Another methodof stabilization is anterior spinal fusions, fixation of any number ofvertebrae to stabilize and prevent movement of the vertebrae.

Another type of conventional treatment is decompressive laminectomy.This procedure involves excision of the laminae to relieve compressionof nerves.

These traditional treatments are subject to a variety of limitations andvarying success rates. Furthermore, none of the described treatmentsputs the spine in proper alignment or return the spine to a desiredanatomy. In addition, stabilization techniques, by holding the vertebraein a fixed position, permanently limit the relative motion of thevertebrae, altering spine biomechanics.

SUMMARY OF THE INVENTION

There is a need for prostheses, installation tools, and methods thatovercome the problems and disadvantages associated with currentstrategies and designs in various treatments for spine pathologies.

The invention provides prostheses, installation tools, and methodsdesigned to replace natural facet joints at virtually all spinal levelsincluding L1-L2, L2-L3, L3-L4, L4-L5, L5-S1, T11-T12, and T12-L1. Theprostheses, installation tools, and methods can restore a desiredanatomy to a spine and give back to an individual a desired range ofrelative vertebral motion. The prostheses, installation tools, andmethods also can lessen or alleviate spinal pain by relieving the sourceof nerve compression or impingement.

For the sake of description, the prostheses that embody features of theinvention will be called either “cephalad” or “caudal” with relation tothe portion of a given natural facet joint they replace. As previouslydescribed, a given natural facet joint has a superior half and aninferior half. In anatomical terms, the superior half of the joint isformed by the vertebral level below the joint (which can thus be calledthe caudal portion of the facet joint, i.e., because it is near thefeet). The inferior half of the joint is formed by the vertebral levelabove the joint (which can thus be called the cephalad portion of thefacet joint, i.e., because it is near the head). Thus, a prosthesisthat, in use, replaces the caudal portion of a facet joint (i.e., thesuperior half) will be called a “caudal” prosthesis. Likewise, aprosthesis that, in use, replaces the cephalad portion of a facet joint(i.e., the inferior half) will be called a “cephalad” prosthesis.

One aspect of the invention provides a prosthesis to replace a cephaladportion of a natural facet joint on a vertebra. The prosthesis includes:an artificial facet joint bearing element adapted and configured toreplace the cephalad portion of the natural facet joint; and a fixationmechanism (such as a clamp) adapted and configured to attach theartificial facet joint bearing element to the vertebra, the fixationmechanism including a non-invasive support member adapted and configuredto attach to a lamina portion of the vertebra, such as substantially ata spinous process location. The support member may be further adaptedand configured to be in contact with the lamina portion of the vertebraon at least two opposing sides and possibly four surfaces of the laminaportion of the vertebra. The fixation mechanism is preferably furtheradapted and configured to attach the artificial facet joint element tothe vertebra without blocking access to a pedicle portion of thevertebra.

In some embodiments the support member includes first and secondvertebra contact surfaces, the distance between the first and secondvertebra contact surfaces being adjustable. At least one of the firstand second vertebral contact components may be movable with respect tothe other vertebral contact component.

The prosthesis may also include an attachment mechanism attaching theartificial facet joint bearing element to the fixation mechanism. Theattachment mechanism may traverse a midline of the vertebra. Theattachment mechanism may be adapted and configured such that theartificial facet joint bearing element is movable in a cephalad orcaudad direction with respect to the fixation mechanism. In someembodiments the attachment element includes a location element movablein a cephalad or caudad direction with respect to the fixationmechanism.

In some embodiments the artificial facet joint bearing element is aright artificial facet joint bearing element and the natural facet jointis a right natural facet joint, and the prosthesis further includes aleft artificial facet joint bearing element adapted and configured toreplace a cephalad portion of a left natural facet joint. The right andleft artificial facet joint bearing elements may be attached to theattachment element.

Another aspect of the invention provides a prosthesis to replace acephalad portion of a natural facet joint on a vertebra, including anartificial facet joint bearing element adapted and configured to replacethe cephalad portion of the natural facet joint; and a fixationmechanism (such as a clamp) adapted and configured to attach theartificial facet joint bearing element to the vertebra (such as a laminaportion of the vertebra) without penetrating any bone portion of thevertebra. In some embodiments the fixation mechanism may be adapted andconfigured to be in contact with the attachment portion of the vertebraon at least two opposing sides, and possibly on four surfaces, of thevertebra. The fixation mechanism is preferably further adapted andconfigured to attach the artificial facet joint element to the vertebrawithout blocking access to a pedicle portion of the vertebra.

In some embodiments, the fixation mechanism includes first and secondvertebra contact surfaces, the distance between the first and secondvertebra contact surfaces being adjustable, such as by moving one offirst and second vertebral contact components with respect to the othervertebral contact component.

The prosthesis may include an attachment mechanism attaching theartificial facet joint bearing element to the fixation mechanism. Insome embodiments, the attachment mechanism disposes the artificial facetjoint bearing element caudad from the fixation mechanism. In oneembodiment the attachment mechanism traverses a midline of the vertebra.The attachment mechanism may be adapted and configured such that theartificial facet joint bearing element is movable in a cephalad orcaudad direction with respect to the fixation mechanism. In someembodiments the fixation mechanism is a first fixation mechanism and theattachment mechanism is adapted and configured to penetrate a boneportion of the vertebra to form a second fixation mechanism attachingthe artificial bearing element to the vertebra.

In some embodiments, the artificial facet joint bearing element is aright artificial facet joint bearing element and the natural facet jointis a right natural facet joint, with the prosthesis further including aleft artificial facet joint bearing element adapted and configured toreplace a cephalad portion of a left natural facet joint.

Another aspect of the invention provides a prosthesis to replace acephalad portion of a natural facet joint on a vertebra, the prosthesisincluding an artificial facet joint bearing element adapted andconfigured to replace the cephalad portion of the natural facet joint;and means for affixing the artificial facet joint bearing element to thevertebra (such as a lamina portion of the vertebra) without penetratingany bone portion of the vertebra. In some embodiments, the means foraffixing includes first and second components movable with respect toeach other. The prosthesis according to this aspect of the invention mayalso include means for moving the artificial facet joint bearing elementin cephalad and caudad directions with respect to the means foraffixing.

In some embodiments, the artificial facet joint bearing element is aright artificial facet joint bearing element and the natural facet jointis a right natural facet joint, with the prosthesis further including aleft artificial facet joint bearing element adapted and configured toreplace a cephalad portion of a left natural facet joint, and with themeans for affixing including means for affixing the right and leftartificial facet joint bearing elements to the vertebra. The prosthesismay also include means for moving the right and left artificial facetjoint bearing elements in cephalad and caudad directions with respect tothe means for affixing. In some embodiments, the prosthesis may alsoinclude means for affixing the artificial facet joint bearing element tothe vertebra by penetrating a bone portion of the vertebra.

Another aspect of the invention provides a prosthesis to replace rightand left cephalad portions of right and left natural facet joints on avertebra, with the prosthesis including right and left artificial facetjoint bearing elements adapted and configured to replace the cephaladportions of the right and left natural facet joints; and a fixationmechanism adapted and configured to attach the artificial facet jointbearing element to a lamina portion of the vertebra without penetratingany bone portion of the vertebra. The prosthesis may also include anattachment mechanism attaching the right and left artificial facet jointbearing elements to the fixation mechanism. The attachment mechanism maybe adapted and configured to move the right and left artificial jointbearing elements in a cephalad or caudad direction with respect to thefixation mechanism.

Yet another aspect of the invention provides a method for implanting acephalad facet joint prosthesis on a vertebra, with the method includingthe steps of affixing a fixation element to the vertebra (such as alamina portion of the vertebra) without penetrating any bone portion ofthe vertebra; and disposing an artificial facet joint bearing element ina predetermined position with respect to the vertebra. In someembodiments the affixing step may include placing a fixation mechanismin contact with an attachment portion of the vertebra on at least twoopposing sides of the attachment portion of the vertebra, such as byplacing the fixation mechanism in contact with the attachment portion ofthe vertebra on four surfaces of the attachment portion of the vertebra.The fixation mechanism may include first and second vertebral contactcomponents, with the affixing step including moving one of the first andsecond vertebral contact components with respect to the other. Theaffixing step may also include the step of preventing relative movementbetween the first and second vertebral contact components after themoving step. In some embodiments the affixing step includes affixing afixation mechanism to the vertebra without blocking access to a pedicleportion of the vertebra.

The disposing step of this aspect of the invention may include fasteningthe artificial facet joint bearing element to a fixation mechanism, suchas by inserting a fastener through the fixation element. The disposingstep may also include moving the artificial facet joint bearing elementin a cephalad or caudad direction with respect to the vertebra.

In this method, the fixation mechanism may be a first fixationmechanism, with the method further including the step of affixing asecond fixation mechanism to the vertebra by penetrating the vertebra(such as by inserting a fastener into a lamina portion of the vertebra)and possibly attaching the second fixation mechanism to the firstfixation mechanism. The fastener may be inserted through the fixationelement across a midline of the vertebra, and the artificial facet jointbearing element may be attached to the fastener.

In some embodiments of the method, the artificial facet joint bearingelement is a right artificial facet joint bearing element, with thedisposing step further including disposing a left artificial facet jointbearing element in a predetermined position with respect to thevertebra.

Other features and advantages of the inventions are set forth in thefollowing Description and Drawings, as well as in the appended Claims.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a lateral elevation view of a normal human spinal column;

FIG. 2 is a superior view of a normal human lumbar vertebra;

FIG. 3 is a lateral elevation view of a vertebral lumbar facet joint;

FIG. 4 is a posterior view of an artificial facet joint prosthesisinstalled in a patient according to one embodiment of this invention;

FIG. 5 is a left side view of the embodiment of FIG. 4, as installed ina patient;

FIG. 6 is yet another view of the embodiment of FIG. 4, as installed ina patient;

FIG. 7 is a top view of the artificial facet joint prosthesis of theembodiment of FIG. 4;

FIG. 8 is a left view of the artificial facet joint prosthesis of theembodiment of FIG. 4;

FIG. 9 is a posterior view of the artificial facet joint prosthesis ofthe embodiment of FIG. 4;

FIG. 10 is an anterior view of the artificial facet joint prosthesis ofthe embodiment of FIG. 4;

FIG. 11 is a bottom view of the artificial facet joint prosthesis of theembodiment of FIG. 4;

FIG. 12 is an exploded view of part of the cephalad portion of theartificial facet joint prosthesis of the embodiment of FIG. 4;

FIG. 13 is an artificial facet joint prosthesis according to anotherembodiment of this invention;

FIG. 14 is a top view of the artificial facet joint prosthesis of theembodiment of FIG. 13;

FIG. 15 is a posterior view of the artificial facet joint prosthesis ofthe embodiment of FIG. 13;

FIG. 16 is a left side view of the artificial facet joint prosthesis ofthe embodiment of FIG. 13;

FIG. 17 is a posterior view of the caudal portion of the artificialfacet joint prosthesis of the embodiment of FIG. 3;

FIG. 18 is a view of the cephalad bearing elements of the artificialfacet joint prosthesis of the embodiment of FIG. 3;

FIG. 19 is an exploded view of a clamp assembly according to theembodiment of FIG. 13; and

FIG. 20 is a cross-sectional view of the clamp assembly of FIG. 19.

The invention may be embodied in several forms without departing fromits spirit or essential characteristics. The scope of the invention isdefined in the appended claims, rather than in the specific descriptionpreceding them. All embodiments that fall within the meaning and rangeof equivalency of the claims are therefore intended to be embraced bythe claims.

DETAILED DESCRIPTION OF THE INVENTION

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention that may be embodied inother specific structure. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

FIGS. 4-12 show artificial cephalad and caudal facet joint prosthesesfor replacing a natural facet joint according to one aspect of theinvention. The cephalad prosthesis has a bearing element 38 with abearing surface 40. In this embodiment, bearing surface 40 has a convexshape. Bearing element 38 and bearing surface 40 may be formed frombiocompatible metals (such as cobalt chromium steel, surgical steels,titanium, titanium alloys, tantalum, tantalum alloys, aluminum, etc.),ceramics, polyethylene, biocompatible polymers, and other materialsknown in the prosthetic arts.

Depending on the patient's disease state, the condition of the patient'snatural facet joint—including the facet joint's strength, location andorientation—may not be acceptable. As shown in FIGS. 4 and 5, therefore,the natural cephalad and caudal facet joint surfaces and the spinousprocess of vertebra 60 have been removed to enable the installation of aprosthetic facet joint without limitations presented by remainingportions of the natural facet joint. Other portions of the vertebra maybe removed as required by the pathology of the patient's vertebra(e).

A fixation mechanism attaches the cephalad prosthesis to vertebra 60. Inthis embodiment of the invention, the fixation mechanism includes anon-invasive support member such as a two-part clamp formed from anupper clamp member 36 and a lower clamp member 41. Upper clamp member 36has a hook with a cephalad directed portion 51, an anteriorly directedportion 37 and a caudad directed portion 39. The anterior surface ofcephalad directed portion 51, the bottom surface of anteriorly directedportion 37 and the posterior surface of caudad directed portion 39 arein contact with a contact portion of the patient's vertebra, shown aslamina portion 62 in FIGS. 4 and 5. Likewise, lower clamp member 41 hasan anteriorly directed portion 42 and a cephalad directed portion 43.The top surface of anteriorly directed portion 42 and the posteriorsurface of cephalad directed portion 43 are also in contact with thecontact portion of the vertebra, such as lamina portion 62 in FIGS. 4and 5.

In this embodiment, the fixation mechanism of the cephalad prosthesisattaches to the lamina of vertebra 60 after removal of the spinousprocess from that vertebra. In other embodiments, the fixation mechanismmay come in contact with other parts of the vertebra and at fewer thanfour contact points, such as by contacting two opposing sides of thevertebral contact portion. In addition, in other embodiments it may notbe necessary to first remove the spinous process.

For purposes of installation and to conform most closely with thepatient's anatomy, upper and lower clamp members 36 and 41 are movablewith respect to each other. As shown in FIG. 12, a posterior cephaladdirected portion 44 of clamp member 41 slides in a slot 45 formedposterior to a body portion 46 of upper clamp member 36. After placingupper clamp member 36 on contact portion 62 of vertebra 60, lower clampmember 41 may be slid upwards until it makes firm contact with contactportion 62 as well. A set screw 47 may be advanced within interiorthreads 48 formed in the posterior portion of upper clamp member 36 tofirmly contact lower clamp member 41 to hold it in place. A nut 49 isthen advanced onto exterior threads 50 formed in the posterior portionof upper clamp member 36 to lock set screw 47 and lower clamp member 41in place.

The cephalad facet joint bearing elements 38 are attached to theassembly via an attachment mechanism. In the embodiment of FIGS. 4-12,the attachment mechanism includes fasteners such as screws 63 insertedthrough the body portion 46 of upper clamp member 36 into a hole formedin each bearing element 38. The angle in which screws 63 are inserted(and, therefore the relative orientation of the cephalad and caudalfacet joint bearing elements) may be determined using tools such asthose described in copending U.S. patent application Ser. No. 10/438,294entitled “Prostheses, Tools and Methods for Replacement of Natural FacetJoints With Artificial Facet Joint Surfaces,” filed May 14, 2003, thedisclosure of which is incorporated herein by reference. As shown inFIGS. 4 and 5, if enough bone around the lamina portion of vertebra 60is left intact, screws 63 may penetrate the lamina to form an additionalfixation mechanism.

In an alternative embodiment, because of the amount of bone removed fromthe patient's vertebra prior to installation of the prosthesis, theattachment mechanism does not penetrate the bone. In this embodiment,the fasteners such as screws 63 are inserted through the body portion 46of upper clamp member 36 into a threaded hole formed in each bearingelement 38 but do not extend through the lamina or any other portion ofthe vertebra. As in the other embodiment, screws 63 traverse the midlineof vertebra 60 and extend caudad from the clamp to provide the bearingelement orientation shown. Other orientations of attachment mechanismsare possible, of course. In addition, the location of bearing elements38 (i.e., in cephalad/caudad directions, left/right, etc.) may beadjusted by using different size or shape fasteners.

The artificial cephalad facet joint prosthesis of FIGS. 4-12 may be usedwith any suitable natural or artificial caudal facet joint members.FIGS. 4-12 show one suitable artificial caudal facet joint prosthesisthat may be used. The caudal prosthesis has a bearing element 52 with abearing surface 54. In this embodiment, bearing surface 54 is concave.Bearing element 52 may be formed from biocompatible metals (such ascobalt chromium steel, surgical steels, titanium, titanium alloys,tantalum, tantalum alloys, aluminum, etc.), ceramics, polyethylene,biocompatible polymers, and other materials known in the prostheticarts, and bearing surface 54 may be formed from biocompatible metals(such as cobalt chromium steel, surgical steels, titanium, titaniumalloys, tantalum, tantalum alloys, aluminum, etc.), ceramics,polyethylene, biocompatible polymers, and other materials known in theprosthetic arts.

In one embodiment, the natural caudal facet surface has been removed,and fixation element 56 attaches the caudal prosthesis to a vertebra 70via a pedicle in an orientation and position that places bearing surface54 in approximately the same location as the natural facet joint surfacethe prosthesis replaces. In an alternative embodiment, the bearingsurface 54 may be placed in a location different than the natural facetjoint surface, either more medial or more lateral, more cephalad or morecaudad, and/or rotated from the natural anatomical orientation andorientation. In addition, in other embodiments the caudal component canbe attached to the vertebral body in addition to the pedicle or to thevertebral body alone.

As shown in the embodiment of FIGS. 4-12, fixation element 56 is a screwattached to bearing element 54 via a hole formed in bearing element 52and is inserted into a pedicle portion 72 of vertebra 70. Other possiblefixation elements include stems, corkscrews, wire, staples, adhesives,bone cements, and other materials known in the prosthetic arts. Fixationelement 56 can also be inserted into the vertebral body in addition toor in place of the pedicle.

In this embodiment, bearing element 52 has a serrated fixation surface57 adapted to contact a contact portion 74 of vertebra 70. This optionalfixation surface 57 helps prevent rotation of the bearing element 52. Inaddition, fixation surface 57 may be coated with bone ingrowth material,and any optional serrations increase the surface area for bone ingrowth.Further details regarding the design and installation of this caudalprosthesis may be found in copending and commonly owned U.S. patentapplication Ser. No. 10/438,294 entitled “Prostheses, Tools and Methodsfor Replacement of Natural Facet Joints With Artificial Facet JointSurfaces,” filed May 14, 2003.

FIGS. 13-20 show another embodiment of the artificial facet jointprosthesis of this invention for replacing a natural facet joint. Thecephalad prosthesis has a bearing element 80 with a bearing surface 82.In this embodiment, bearing surface 82 has a convex shape. Bearingelement 80 and bearing surface 82 may be formed from biocompatiblemetals (such as cobalt chromium steel, surgical steels, titanium,titanium alloys, tantalum, tantalum alloys, aluminum, etc.), ceramics,polyethylene, biocompatible polymers, and other materials known in theprosthetic arts.

A fixation mechanism attaches the cephalad prosthesis to the vertebra.In this embodiment of the invention, the fixation mechanism includes anon-invasive support member such as a two-part clamp formed from anupper clamp member 84 and a lower clamp member 86. Upper clamp member 84has a hook with a cephalad directed portion 88, an anteriorly directedportion 90 and a caudad directed portion 92. The anterior surface ofcephalad directed portion 88, the bottom surface of anteriorly directedportion 90 and the posterior surface of caudad directed portion 92 arein contact with a contact portion of the patient's vertebra (such as thelamina) when the prosthesis is installed in a patient. Likewise, lowerclamp member 86 has a caudad directed portion 94, an anteriorly directedportion 96 and a cephalad directed portion 98. The anterior surface ofcaudad directed portion 94, the top surface of anteriorly directedportion 96 and the posterior surface of cephalad directed portion 98 arealso in contact with the contact portion of the vertebra (such as thelamina) when the prosthesis is installed in a patient. This arrangementof upper and lower clamps provides for contact with the lamina (or othervertebra contact portion) on four sides.

In this embodiment, the fixation mechanism of the cephalad prosthesisattaches to the lamina of vertebra after removal of the spinous processfrom that vertebra. In other embodiments, the fixation mechanism maycome in contact with other parts of the vertebra and at fewer than fourcontact points, such as by contacting two opposing sides of thevertebral contact portion. In addition, in other embodiments it may notbe necessary to first remove the spinous process.

For purposes of installation and to conform most closely with thepatient's anatomy, upper and lower clamp members 84 and 86 are movablewith respect to each other. As shown in FIGS. 19 and 20, a posteriorcephalad directed portion 100 of clamp member 86 slides in a slot 102formed in a body portion 104 of upper clamp member 84. As shown, slot102 places clamp member portion 100 at a 15° angle from vertical, and ashim 106 is placed posterior to clamp member portion 100. Thisorientation may be changed, of course, to meet the needs of thepatient's anatomy.

After placing upper clamp member 84 on the contact portion of thevertebra, lower clamp member 86 may be slid upwards until it makes firmcontact with the contact portion as well. A set screw 108 is thenadvanced within interior threads 110 formed in body portion 104 of upperclamp member 84 to firmly contact lower clamp member 86 to hold it inplace.

The cephalad facet joint bearing elements 80 are attached to theassembly via an attachment mechanism, including a movable locationelement for adjusting the location of bearing elements 80. In thisembodiment, the location element includes a rod 112 to which bearingelements 80 are attached via attachment wings 113. During installation,rod 112 is movable in a space formed by a pair of inserts 114 and 116 toadjust the location of bearing elements 80. Once the location has beenset, inserts 114 and 116 are tightened against rod 112 by advancing asecond set screw 118 against insert 116 via internal threads 120 formedin the body portion of the upper clamp member. A nut 122 is thenadvanced onto exterior threads 124 formed in the body portion of upperclamp member 84 to the other components in place.

The artificial cephalad facet joint prosthesis of FIGS. 13-16 and 18-20may be used with any suitable natural or artificial caudal facet jointmembers. FIGS. 13-17 show one suitable artificial caudal facet jointprosthesis that may be used. The caudal prosthesis has a bearing element130 with a bearing surface 132. In this embodiment, bearing surface 132is concave. Bearing element 130 and bearing surface 132 may be formedfrom biocompatible metals (such as cobalt chromium steel, surgicalsteels, titanium, titanium alloys, tantalum, tantalum alloys, aluminum,etc.), ceramics, polyethylene, biocompatible polymers, and othermaterials known in the prosthetic arts.

To install the artificial caudal prosthesis of this embodiment, thenatural caudal facet surface is removed, and a fixation element (such asa screw) is inserted through holes 134 formed in arms 136 extending frombearing elements 130 into pedicle portions of a vertebra to attach thecaudal prosthesis to the vertebra in an orientation and position thatplaces bearing surface 132 in approximately the same location as thenatural facet joint surface the prosthesis replaces. The spacing betweenbearing elements 130 is set by a bar 138. In an alternative embodiment,the bearing surface may be placed in a location different than thenatural facet joint surface, either more medial or more lateral, morecephalad or more caudad, and/or rotated from the natural anatomicalorientation. In addition, in other embodiments the caudal component canbe attached to the vertebral body in addition to the pedicle or to thevertebral body alone. Other possible fixation elements include stems,corkscrews, wire, staples, adhesives, bone cements, and other materialsknown in the prosthetic arts.

As shown in the preceding embodiments of the invention, unlike otherfacet joint prostheses that attach to the pedicle, the use of one ormore posterior elements of the vertebra to attach the cephalad facetjoint prosthesis of this invention does not block access to the pediclearea, leaving this area free to be used to attach other prostheses ordevices. Other embodiments of the invention may block the pedicle area,of course, without departing from the scope or spirit of the invention.Also, in some embodiments, the entire prosthesis other than the bearingsurface may be coated with bone ingrowth material.

The above described embodiments of this invention are merely descriptiveof its principles and are not to be limited. The scope of this inventioninstead shall be determined from the scope of the following claims,including their equivalents.

1. A method of surgery comprising: providing a spinal implant adaptedand configured to replace a portion of a first vertebra; attaching thespinal implant to the first vertebra via a fixation mechanism, whereinthe fixation mechanism comprises a non-invasive support member adaptedand configured to attach to the first vertebra, wherein the supportmember comprises first and second vertebra contact surfaces; andarticulating the spinal implant to provide movement between the firstvertebra and an adjacent second vertebra.
 2. The method of claim 1,wherein the distance between the first and second vertebra contactsurfaces is adjustable.
 3. The method of claim 1, further comprisingattaching the fixation mechanism to a spinous process of the firstvertebra.
 4. The method of claim 1, further comprising attaching thefixation mechanism to a lamina of the first vertebra.
 5. The method ofclaim 4, wherein the fixation mechanism is further adapted andconfigured to be in contact with the lamina portion of the vertebra onat least two opposing sides of the lamina portion of the first vertebra.6. The method of claim 1, further comprising providing an attachmentmechanism to attach the spinal implant to the fixation mechanism.
 7. Themethod of claim 6, wherein the attachment mechanism is adapted andconfigured such that the spinal implant is moveable in a cephalad orcaudal direction with respect to the fixation mechanism.
 8. A method ofsurgery comprising: providing a spinal implant adapted and configured toreplace a portion of a joint; attaching the spinal implant to a firstvertebra via a fixation mechanism, wherein the fixation mechanism isconfigured to contact the first vertebra without any penetration of anybone portion of the first vertebra; and articulating the spinal implantto provide movement between the first vertebra and an adjacent secondvertebra.
 9. The method of claim 8, further comprising attaching thefixation mechanism to a spinous process of the first vertebra.
 10. Themethod of claim 8, further comprising attaching the fixation mechanismto a lamina portion of the first vertebra.
 11. The method of claim 10,wherein the fixation mechanism is further adapted and configured to bein contact with the lamina portion of the first vertebra on at least twoopposing sides of the lamina portion of the first vertebra.
 12. Themethod of claim 11, wherein the fixation mechanism is further adaptedand configured to be in contact with the lamina portion of the vertebraon four sides of the lamina portion of the first vertebra.
 13. Themethod of claim 8, further comprising attaching the spinal implant to afirst vertebra via a fixation mechanism without blocking access to apedicle portion of the vertebra.
 14. A method of surgery comprising:providing a spinal implant adapted and configured to replace a portionof a joint; attaching the spinal implant to a first vertebra via afixation mechanism, wherein the spinal implant is attached to thefixation mechanism via an attachment mechanism; and articulating thespinal implant between the first vertebra and an adjacent secondvertebra.
 15. The method of claim 14, wherein the attachment mechanismis adapted and configured to traverse a midline of the first vertebra.16. The method of claim 14, further comprising attaching the fixationmechanism to a lamina portion of the first vertebra.
 17. The method ofclaim 16, wherein the fixation mechanism is adapted and configured to bein contact with the lamina portion of the first vertebra on at least twoopposing sides of the lamina portion.
 18. The method of claim 14,wherein the attachment mechanism is adapted and configured such that thespinal implant is moveable in a cephalad or caudad direction withrespect to the fixation mechanism.
 19. The method of claim 14, whereinthe attachment mechanism comprises a location element moveable in acephalad or caudad direction with respect to the fixation mechanism. 20.The method of claim 14, wherein the fixation mechanism comprises aclamp.